Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.
Dimension Vista System - Enzyme Calibrator (2014-01-20)
- Starting date:
- January 20, 2014
- Posting date:
- February 11, 2014
- Type of communication:
- Medical Device Recall
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Medical Devices
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- Dimension Vista System - Enzyme Calibrator
There have been reports of quality control (QC) shifts with pseudocholinesterase (PCHE) and imprecision during PCHE calibration with Dimension Vista enzyme 1 calibrator (ENZ 1 cal) lots 3FD034 and 3HD012. Investigation by Siemens confirms a loss of PCHE activity in the affected lots of enzyme 1 calibrator, causing an elevation of qc by as much as 80% and in some instances, imprecision of replicates during calibration.
A. Dimension Vista System - Enzyme Calibrator
Lot or serial number
Model or catalog number
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
- Date modified: